Family-Based Behavioral Treatment for Childhood Survivors of Acute Lymphoblastic Leukemia
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Appropriateness of Family-Based Behavioral Treatment as measured by Intervention Appropriateness Measure (IAM)
研究概览
简要总结
A single-arm, non-randomized four-month trial of the adapted family-based behavioral weight loss treatment (FBT) intervention will be conducted to evaluate its acceptability, feasibility, and preliminary indications of efficacy including measures of relative weight change and associated secondary outcomes (e.g., weight related health behaviors, health related quality of life), among 40 childhood acute lymphoblastic leukemia (ALL) survivors and their families.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •English-speaking caregiver-child dyads
- •Children must be between ages of 5-18
- •Child must be overweight or obese (defined as a BMI greater than the 85th percentile for their age and sex)
- •Child must have been diagnosed with ALL
- •Child must have completed their final cancer treatment and currently be in remission
- •Only children and adolescents who have not yet graduated from high school and are living at home with their caregiver at least 50% of the time will be invited to enroll
- •Participating caregivers and children must be able to perform some level of exercise
排除标准
- •Children who are wards of the state
- •Caregivers and/or children who are taking a weight altering medication without being at current dosage for at least six months and weight stable for at least three months
- •Caregivers and/or children who are actively involved in another intensive weight loss program
- •Caregivers and/or children who have undergone weight loss surgery within the last two years and/or who are still losing weight
- •Caregivers and/or children with certain diagnosed psychiatric conditions (e.g., history of/active eating disorder, developmental delays/intellectual disabilities such as Down's syndrome and severe presentations of autism spectrum disorder, active suicidal ideation, psychotic symptoms, manic or hypomanic episodes, severe substance use disorder) that would interfere with their ability to participate
- •Caregivers and/or children with certain chronic medical conditions (e.g., type 1 diabetes, muscular dystrophy) for whom participation may be contraindicated
结局指标
主要结局
Appropriateness of Family-Based Behavioral Treatment as measured by Intervention Appropriateness Measure (IAM)
时间窗: At completion of intervention (estimated to be at 4 months)
-4 questions about appropriateness of the intervention measure. Answers range from completely disagree to completely agree. The higher the score indicates higher appropriateness of the intervention measure.
Acceptability of Family-Based Behavioral Treatment as measured by The Acceptability of Intervention Measure (AIM)
时间窗: At completion of intervention (estimated to be at 4 months)
-4 questions about acceptability of the intervention measure. Answers range from completely disagree to completely agree. The higher the score indicates higher acceptability of the intervention measure.
Acceptability of Family-Based Behavioral Treatment as measured by the Client Satisfaction Questionnaire (CSQ-8)
时间窗: At completion of intervention (estimated to be at 4 months)
-8 questions asking about satisfaction of intervention. The CSQ-8 offers four response options for each item (1-4) and an overall score is calculated by summing the respondent's rating score for each item. Scores range from 8-32 with higher scores indicating higher satisfaction.
Feasibility of Family-Based Behavioral Treatment as measured by Feasibility of Intervention Measure (FIM)
时间窗: At completion of intervention (estimated to be at 4 months)
-4 questions about feasibility of the intervention measure. Answers range from completely disagree to completely agree. The higher the score indicates higher feasibility of the intervention measure.
次要结局
- Change in dietary intake(Baseline, end of intervention (at 4 months), 6 months, and 12 months)
- Change in relative weight(Baseline, end of intervention (at 4 months), 6 months, and 12 months)
- Change in physical activity as measured by HBSC adaptation(Baseline, end of intervention (at 4 months), 6 months, and 12 months)
- Change in relative height (children only)(Baseline, end of intervention (at 4 months), 6 months, and 12 months)
- Change in physical activity as measured by International Physical Activity Questionnaire (IPAQ) (short)(Baseline, end of intervention (at 4 months), 6 months, and 12 months)